FDA.reportPublic FDA data

Application 065205

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET, CHEWABLE;ORAL200MG;EQ 28.5MG BASENoNo
002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET, CHEWABLE;ORAL400MG;EQ 57MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2270Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2270Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2270Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2270Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2272Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2272Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2272Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2272Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42814ORIG2008-07-31